BRIEF-GSK Withdraws U.S. Marketing Authorisation For Blood Cancer Drug Blenrep
- Country:
- United States
GSK plc: * GSK PLC - BLENREP US UPDATE
* GSK PLC - BLENREP US UPDATE * GSK - HAS INITIATED PROCESS FOR WITHDRAWAL OF US MARKETING AUTHORISATION FOR BLENREP
* GSK: INITIATED PROCESS FOR WITHDRAWAL OF US MARKETING AUTHORISATION FOR BLENREP * GSK - REQUEST BASED ON OUTCOME OF DREAMM-3 PHASE III CONFIRMATORY TRIAL, WHICH DID NOT MEET REQUIREMENTS OF US FDA ACCELERATED APPROVAL REGULATIONS
* GSK - PATIENTS CURRENTLY BEING TREATED WITH BLENREP SHOULD CONSULT THEIR HEALTHCARE PROVIDER * GSK - PATIENTS ALREADY ENROLLED IN BLENREP REMS PROGRAMME WILL HAVE OPTION TO ENROL IN A COMPASSIONATE USE PROGRAMME TO CONTINUE TO ACCESS TREATMENT Source text for Eikon: Further company coverage:
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